On February 2nd, 2018, Creodent Prosthetics announced that its facility located in Manhattan, New York, successfully passed an inspection by the US Food and Drug Administration (FDA).
The inspection was carried out by a Senior FDA Inspector and lasted 1 day. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP), and no Form 483 observations were issued. The Quality Management Systems and 510(k) products passed all requirements.
A public report of the inspection will appear in the FDA database within 30 days.